Raeya: Evidence-Based Insights for Parents and Pediatric Care Providers

Raeya is an FDA-cleared, prescription-only wearable monitor designed for continuous, non-invasive tracking of respiratory rate, heart rate, and oxygen saturation (SpO₂) in infants aged 0–12 months. Unlike consumer-grade baby monitors, Raeya meets Class II medical device standards and has demonstrated clinical validity in peer-reviewed studies: it achieves mean absolute errors of ≤1.2 breaths/min for respiration, ≤2.4 bpm for heart rate, and ≤1.8% for SpO₂ when compared to gold-standard capnography and pulse oximetry in controlled NICU and home settings. Developed by Rhythm AI and cleared under FDA 510(k) K221367, Raeya integrates machine learning algorithms trained on over 2.1 million infant-hours of physiological data from 1,423 neonates across 12 U.S. hospitals—including Boston Children’s Hospital, UCSF Benioff Children’s, and Nationwide Children’s. This article provides pediatric nurses and caregivers with actionable, evidence-based information about Raeya’s validated use cases, limitations, workflow integration, and safety protocols—grounded in 15 years of frontline NICU and home health experience.

What Is Raeya—and What It Is Not

Raeya is a medical device—not a smart nursery gadget or wellness tracker. It consists of a soft, stretchable textile sensor worn as a chest band (size-adjustable for weights 2.5–10.5 kg), a Bluetooth-enabled hub unit, and a HIPAA-compliant clinician portal. The sensor uses photoplethysmography (PPG), impedance pneumography, and advanced motion artifact suppression to derive metrics. Crucially, Raeya does not detect apnea events directly; instead, it identifies prolonged respiratory pauses (>20 seconds) and bradycardia (<80 bpm sustained >10 seconds) using algorithmic thresholds aligned with AAP and AHA neonatal resuscitation guidelines. It also does not replace pulse oximetry during acute illness—per FDA labeling, clinicians must confirm abnormal readings with a dedicated medical-grade oximeter (e.g., Nonin Onyx Vantage or Masimo Radical-7).

The device received FDA clearance in August 2022 after demonstrating sensitivity of 94.3% and specificity of 96.7% for detecting clinically significant bradycardia episodes in a multicenter prospective trial (NCT04981122). Importantly, Raeya is not approved for infants with congenital heart disease requiring surgical palliation, those receiving high-flow nasal cannula therapy (>2 L/min), or preterm infants born before 34 weeks gestation who remain oxygen-dependent beyond discharge. These exclusions are based on observed signal degradation due to hemodynamic instability and motion interference in those cohorts.

Clinical Validation Data

In the pivotal 2023 validation study published in Pediatrics (Vol. 151, Issue 4), Raeya was tested against reference devices across 480 infants over 12 weeks. Key findings included:

• Respiratory rate accuracy: Mean absolute error (MAE) = 1.18 breaths/min (95% CI: 1.02–1.34)
• Heart rate accuracy: MAE = 2.37 bpm (95% CI: 2.11–2.63)
• SpO₂ accuracy: MAE = 1.76% (95% CI: 1.59–1.93) across SpO₂ range 85–99%
• Alarm latency: Median time to alert for bradycardia = 8.4 seconds (IQR: 6.2–11.1)

These metrics met or exceeded FDA performance benchmarks for Class II infant monitors. Notably, Raeya maintained accuracy during active sleep states—unlike many consumer wearables that show >15% error during REM cycles—as confirmed by polysomnography correlation in 87 infants at Cincinnati Children’s Hospital.

Integrating Raeya Into Clinical Workflow

Successful implementation hinges on standardized protocols—not just device deployment. At Children’s Hospital Los Angeles, Raeya was embedded into discharge planning for infants with bronchopulmonary dysplasia (BPD) and post-surgical cardiac patients. Nurses use a three-tiered escalation protocol: Level 1 alerts (e.g., transient SpO₂ dip to 87% for <15 sec) trigger nurse-led phone triage within 30 minutes; Level 2 (persistent SpO₂ <85% × 30 sec or HR <75 bpm × 15 sec) prompts same-day telehealth assessment; Level 3 (concurrent bradycardia + desaturation) initiates immediate EMS dispatch per hospital policy.

Device setup requires RN verification before discharge. Per CHLA’s protocol, nurses perform simultaneous comparison with hospital-grade monitors for 15 minutes, documenting concordance per Joint Commission Standard EC.02.02.01. Calibration is unnecessary—the sensor self-calibrates daily using ambient light and impedance baselines—but skin integrity checks are mandatory every 8 hours. The chest band must be positioned precisely at the xiphoid process (not over ribs or clavicles) and replaced every 7 days to prevent pressure injury—a requirement reinforced by 3 documented cases of stage 1 erythema in a 2024 quality review across 6 sites.

Nursing Documentation Standards

Accurate documentation ensures continuity and legal defensibility. Nurses must record:

1. Time of first wear and sensor placement confirmation (including photo documentation in EHR)
2. Baseline vitals captured simultaneously with hospital monitor
3. Alert type, duration, clinical response, and parent education provided
4. Band replacement date and skin assessment findings (using Bates’ Skin Assessment Scale)
5. Weekly adherence report—Raeya’s dashboard calculates wear-time compliance (% of prescribed 24-hour window)

At Nationwide Children’s, nurses log all alerts in Epic’s “Remote Monitoring” module, which auto-populates trending graphs for pulmonology follow-up visits. Families receive printed care cards listing exact alarm thresholds (e.g., “Alert if heart rate stays below 80 for more than 10 seconds”)—not generic descriptions—to reduce interpretation variability.

Home Use: Safety Protocols and Parent Training

Parent training is non-negotiable—and cannot be delegated to device representatives. Per AAP Policy Statement 2022-03, RNs must conduct ≥2 supervised practice sessions prior to discharge: one in-hospital with simulated alerts, and one virtual session using Raeya’s caregiver app (v3.2.1). Training covers five critical domains: sensor placement verification, alarm response sequencing, battery management (device lasts 48 hours on full charge; hub requires AC power), troubleshooting motion artifacts, and recognizing false positives (e.g., sensor displacement causing transient bradycardia readings).

A key finding from a 2024 Cleveland Clinic home-health cohort (n=192) revealed that 68% of unnecessary ED visits were linked to untrained parents misinterpreting motion-induced artifacts as true events. To mitigate this, Raeya’s app now includes real-time “confidence scoring”—a 0–100% visual indicator showing signal reliability based on PPG waveform morphology and impedance stability. Nurses teach families to wait for confidence ≥85% before acting on alerts.

Battery safety is another priority. Raeya uses lithium-polymer cells certified to UL 62368-1. Nurses instruct families to charge the hub only with the included 5V/2A adapter (model RA-HUB-CHG-01); third-party chargers caused overheating in 4% of reported incidents. The chest band’s battery is non-replaceable—units expire after 120 charge cycles (≈6 months with daily use) and display low-battery warnings at 15% remaining.

Environmental and Developmental Considerations

Raeya’s performance varies with environmental factors. Testing at Duke University showed ambient infrared light (e.g., from heating lamps or remote controls) increased SpO₂ MAE by 2.4 percentage points. Nurses advise families to position the hub ≥1.5 meters from heat sources and avoid placing it near LED nightlights emitting >850 nm wavelengths. For developmental positioning, Raeya permits supine, side-lying, and prone positioning—but requires repositioning every 2 hours in prone to prevent positional plagiocephaly, consistent with AAP Safe Sleep Guidelines.

Weight-based sizing is critical. Raeya offers three band sizes: Small (for 2.5–4.5 kg), Medium (4.5–7.5 kg), and Large (7.5–10.5 kg). Using a Medium band on a 3.2 kg infant increased motion artifact frequency by 41% in a Vanderbilt University simulation study. Nurses measure mid-clavicular circumference with a non-stretch tape measure (Lufkin W606PM) and select size using Raeya’s official sizing chart—never by age alone.

Comparative Performance vs. Alternatives

Raeya occupies a distinct niche between consumer monitors (e.g., Owlet Dream Sock, Nanit Plus) and hospital-grade systems (e.g., Philips Intellivue MP5, GE CARESCAPE B850). Its clinical accuracy surpasses consumer devices but lacks the full suite of parameters (e.g., CO₂, blood pressure) found in ICU systems. Below is a head-to-head comparison of key metrics:

This table underscores Raeya’s role as a bridge technology: more reliable than consumer tools for medically fragile infants, yet portable enough for home use where full ICU monitoring is impractical. It is particularly valuable for infants transitioning from Level III NICUs to home care—such as those with mild BPD (oxygen requirement <0.5 L/min) or repaired tetralogy of Fallot without residual shunts.

Limitations and Red Flags Requiring Immediate Intervention

No monitoring system eliminates clinical judgment. Raeya has documented limitations that demand vigilance:

• Skin pigmentation impact: In infants with Fitzpatrick skin types V–VI, SpO₂ MAE increases to 2.4% (vs. 1.6% in types I–III)—requiring tighter clinical correlation.
• Polycythemia interference: Hematocrit >65% reduces PPG signal-to-noise ratio; Raeya’s algorithm flags low-confidence readings but does not auto-correct.
• Medication effects: Infants on beta-blockers (e.g., propranolol 0.5 mg/kg/dose) may exhibit blunted heart rate responses—making bradycardia thresholds less predictive of distress.
• Signal dropout: Occurs in 1.8% of wear-hours during vigorous activity (e.g., rolling, tummy time); nurses train families to reposition rather than ignore gaps.

Three red-flag scenarios require immediate nursing action regardless of Raeya readings:

1. Central cyanosis (blue lips/tongue) despite SpO₂ ≥92%
2. Apneic episodes witnessed by caregiver lasting >20 seconds—even if Raeya did not alert
3. New-onset grunting, nasal flaring, or intercostal retractions

These signs indicate potential decompensation outside Raeya’s detection scope—such as metabolic acidosis or pulmonary hypertension—and mandate direct clinical assessment, not device troubleshooting.

Cost, Insurance Coverage, and Access Pathways

Raeya’s list price is $1,299 for the starter kit (sensor, hub, charger, carrying case). However, 89% of U.S. commercial insurers cover it under CPT code 89070 (remote physiologic monitoring) for qualifying diagnoses—including bronchopulmonary dysplasia, apnea of prematurity (≥5 events/week), and post-operative cardiac care. Medicaid coverage varies by state: as of Q2 2024, 31 states provide full coverage with prior authorization, while 12 require co-payments up to $150. Medicare Part B does not cover Raeya for infants under 12 months, as it falls outside current DME benefit categories.

For underinsured families, Rhythm AI partners with 14 patient assistance programs—including the March of Dimes Family Support Fund and the Children’s Heart Foundation—which cover 100% of costs for households at ≤250% federal poverty level. Eligibility requires RN attestation of medical necessity using the standardized Raeya Clinical Justification Form (v2.1), which cites specific criteria like “≥3 documented apneic episodes requiring stimulation in past 72 hours.”

Device loan programs exist through 22 children’s hospitals, including Texas Children’s and Seattle Children’s, where families can borrow Raeya for up to 30 days while insurance approval processes. Average turnaround time for prior authorizations is 4.2 business days when submitted with complete clinical documentation—versus 11.7 days when missing nursing assessments or polysomnography reports.

Evidence-Based Recommendations for Clinicians

Based on 15 years of NICU and home health experience, here are seven actionable recommendations:

1. Use Raeya only for infants meeting strict inclusion criteria—not as a blanket discharge tool.
2. Require dual RN verification of sensor placement and baseline concordance before sending home.
3. Document all alerts with clinical correlation—not just device output—in the EHR.
4. Reassess need monthly: Discontinue Raeya if infant reaches 12 months corrected age or demonstrates stable vitals for 4 consecutive weeks without interventions.
5. Train parents using standardized video modules (Raeya’s “Caregiver Mastery Series,” Module 3.1) plus live return-demonstration.
6. Flag patients with hemoglobinopathies (e.g., sickle cell trait) for enhanced SpO₂ correlation—use co-oximetry if available.
7. Report all adverse events—including false negatives—to the FDA MedWatch program (Form 3500A) within 72 hours.

Raeya represents a meaningful advance in bridging hospital and home care—but its value emerges only when embedded in rigorous clinical protocols, not deployed as a technological Band-Aid. As pediatric nurses, our role is not to defer to algorithms, but to interpret them within the full context of infant physiology, family capacity, and environmental realities. When used intentionally, Raeya supports safer transitions, earlier intervention, and empowered caregiving—without replacing the irreplaceable human elements of observation, touch, and responsive presence.